Terumo and Quirem welcome an important milestone for QuiremSpheres® in the Netherlands and in Europe. QuiremSpheres® is now reimbursed for liver-dominant, non-resectable, colorectal liver metastases in the salvage setting1, as concluded by the Dutch National Healthcare Institute ('Zorginstituut'). The treatment consists of the injection of holmium-microspheres in the main liver artery with the purpose of destroying the cancer cells and is referred to as radioembolization or selective internal radiation therapy (SIRT). The National Healthcare Institute concludes that this innovative treatment with holmium-166 microspheres, which has been developed in the Netherlands, meets "established medical science and medical practice"2 for this indication.
QuiremSpheres®, the next generation of SIRT microspheres, are the only commercially available microspheres that contain the radioactive isotope holmium-166. Recent trials have shown the safety and efficacy of holmium microspheres for the treatment of advanced liver cancer.3 QuiremSpheres® can be visualized by means of both SPECT and MRI. This allows clinicians to assess quantitatively the distribution of microspheres in the liver enabling the dose to tumor and dose to normal tissue to be calculated accurately. This Dutch innovation fits within a trend in the field of radiotherapy to verify the absorbed radiation dose after the treatment.4
This radiotherapeutic treatment with holmium-166 microspheres has been developed in the University Medical Centre in Utrecht (UMCU) during a 20-year period. "This is very good news for the Interventional Oncology community as it expands the available options to treat patients with non-resectable colorectal liver metastases. QuiremSpheres® have the potential to further improve the outcome of the treatment. It is rewarding to see that, after 20 years of clinical research at our hospital, it is now confirmed that QuiremSpheres® are part of the standard care for the treatment of non-resectable liver metastases", said Prof. Marnix Lam, Head of Nuclear Medicine at the University Medical Center Utrecht.
"The decision of the National Healthcare Institute to make QuiremSpheres® available for doctors and their patients is a positive development for SIRT in the Netherlands", said Peter Coenen, President of Interventional Systems Terumo EMEA. "We strongly believe that the unique imaging capabilities of QuiremSpheres® have the potential to create a paradigm shift in the further development of this therapy. The decision to reimburse this treatment is an important milestone towards realizing its full potential".
Jan Sigger, CEO of Quirem Medical B.V., the manufacturer of QuiremSpheres®, said: "We are most pleased that reimbursement for QuiremSpheres® is now available in the Netherlands. The decision of the National Healthcare Institute shows recognition and acknowledgement for the therapeutic value of our product".
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over US$5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
Quirem Medical is an emerging medical device company with a mission to develop the next generation microspheres for targeted interventional treatment of liver malignancies. It is based in Deventer, the Netherlands, and is a spin-off company from the University Medical Centre in Utrecht.
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1 Zorginstituut, 'Standpunt holmium-166 radioembolisatie (QuiremSpheresâ) bij inoperabele levertumoren', 2018, p.5, p.43
3 Smits et al, Holmium-166 radioembolisation in patients with unresectable, chemorefractory liver metastases (HEPAR trial): a phase 1, dose-escalation study, Lancet Oncology 2012, oct;13(10):1025-34 ; Prince et al, 'Efficay of radioembolization with holmium-166 microspheres in salvage patients with liver metastases', Journal of Nuclear Medicine, sept.2017
4 Council Directive 2013/59/Euratom, effective Feb 6th 2018